(167 days)
The optional "Complete Pediaric" software option mineral content (BMC), bone nineral density (BMD) and body composition (lean body mass and fat mass) in patients from birth to 20 years of age. The software provides a comparison of measured variables obtained by dual energy x-ray absorpionery to a database of reference values for patients 5-19 years of age. These data can be used for comparative purposes at the sole discretion of the software does not provide a reference population for comparative purposes for patients younger than 5 years of age.
Optional Orthopedic software estimates periprosthetic BMD of an orthopedic hip or knee implant (pre- and post-surgery).
enCORE software is used on GE Lunar DXA bone densitometers. Release 16 of the enCORE software (enCORE 16 or enCORE 16.xx) includes some feature enhancements. The software will now expand upon its previously cleared pediatric indication (K001812) by providing a "Complete Pediatric" software that can measure the bone mineral content (BMC), bone mineral density (BMD) and body composition (lean body mass and fat mass) in patients from birth to 20 years of age. The software will also provide a comparison of measured variables obtained by dual energy x-ray absorptiometry to a database of reference values for patients 5-19 years of age. The software will also expand its previously cleared orthopedic hip indication (K972517) to include estimates of the BMD of the knee before and after joint implant.
The GE Lunar DXA bone densitometers measure the bone mineral density (BMD), lean and fat tissue mass and calculate derivative values of bone mineral content (BMC), area, soft tissue mass, regional soft tissue mass, total soft tissue mass, fat free mass, regional/total soft tissue mass ratio, % fat, region % fat, total body % fat, Android % fat, Gynoid % fat, Android/Gynoid ratio (A/G ratio) and Body Mass Index (BMI).
GE Healthcare's enCORE version 16 software for Lunar DXA Bone Densitometers expands its pediatric indication to include patients from birth to 20 years of age and its orthopedic hip indication to include knee BMD estimates before and after joint implant.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state specific acceptance criteria (e.g., numerical thresholds for accuracy, precision, sensitivity, or specificity) or quantitative performance metrics for the enCORE version 16 software.
Instead, the submission primarily focuses on demonstrating substantial equivalence to predicate devices through verification and validation testing, confirming that the new features (expanded pediatric age range and knee orthopedic analysis) do not introduce new safety concerns and perform as well as existing devices.
The "Conclusion" section indirectly serves as a high-level performance claim:
"It does not result in any new potential safety risks, has the same technological characteristics, and performs as well as the devices currently on the market."
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Expanded Pediatric Indication (Birth to 20 years) | Effective at measuring BMC, BMD, and body composition. Provides comparison to reference values for patients 5-19 years. Does not result in new potential safety risks. Performs as well as predicate devices. |
| Expanded Orthopedic Hip Indication (Knee BMD) | Estimates periprosthetic BMD of an orthopedic hip or knee implant (pre- and post-surgery). Does not result in new potential safety risks. Performs as well as predicate devices. |
| Overall Safety and Effectiveness | Substantially equivalent to other marketed devices with similar indications for use. Has the same technological characteristics. |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Bench testing was performed to verify the effectiveness of the expanded population range of the 'Complete Pediatric' software application from birth to 20 years as well as add the knee as an additional anatomic site for the orthopedic software application."
- Sample Size: The document does not specify the sample size for the bench testing performed.
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. The term "bench testing" suggests that patient data might not have been used in the traditional clinical trial sense for this specific verification, but rather phantoms or historical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not mention the use of experts to establish ground truth for a test set. The verification approach was primarily "bench testing," which typically refers to technical and performance validation in a lab setting rather than expert human interpretation.
4. Adjudication Method for the Test Set
Since an expert-based ground truth establishment is not mentioned, an adjudication method is not applicable or described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not done. The submission explicitly states: "The subject of this premarket submission, enCORE version 16 Software Release for the GE Lunar DXA Bone Densitometers, did not require clinical studies to support substantial equivalence." This indicates that no studies comparing human reader performance with and without AI assistance were conducted or deemed necessary for this submission.
6. Standalone (Algorithm Only) Performance
The document does not separately report standalone (algorithm-only) performance metrics in terms of diagnostic accuracy that might typically be seen with CADe/CADx devices. The performance is described in the context of the device's expanded capabilities (measuring BMC, BMD, body composition, and estimating periprosthetic BMD) and its overall substantial equivalence to predicate devices. The "bench testing" described implies verification of the algorithm's output against expected technical performance rather than a clinical diagnostic accuracy trial.
7. Type of Ground Truth Used
For the bench testing, the type of "ground truth" would likely involve technical standards, phantom measurements, and comparisons against established predicate device performance. The document focuses on "effectiveness of the expanded population range" and adding a new anatomical site, implying that the ground truth related to accurate measurement of bone density, bone mineral content, and body composition within the defined age range and for the new anatomical site was validated. This would typically involve using known reference points or established measurement techniques.
8. Sample Size for the Training Set
The document does not specify a training set sample size. This submission is for new software features (expanded pediatric range and knee analysis) for an existing device. It's possible that the core algorithms were developed or trained using data prior to this specific submission, but details are not provided here. The changes are presented as "feature enhancements" and expansions of previously cleared indications, suggesting modification rather than a completely new algorithm development needing a separate training set description.
9. How the Ground Truth for the Training Set Was Established
As no training set is described, the method for establishing its ground truth is not provided.
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GE Healthcare
510(k) Premarket Notification Submission
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510(k) Summary
In occordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | November 27. 2013 |
|---|---|
| Submitter: | GE Healthcare (GE Medical Systems Ultrasound & Primary CareDiagnostics, LLC) |
| 3030 Ohmeda DriveP.O. Box 7550 | |
| Madison, WI 53707 | |
| Primary ContactPerson: | Chris Paulik |
| Regulatory Affairs Leader | |
| GE Healthcare (GE Medical Systems Ultrasound & Primary CareDiagnostics, LLC) | |
| Telephone: (262) 548-2010 | |
| Email: Christopher.Paulik@med.ge.com | |
| Secondary ContactPerson: | Steven KachelmeyerRegulatory Affairs DirectorGE Healthcare (GE Medical Systems Ultrasound & Primary CareDiagnostics, LLC)Telephone: (262) 548 2432Email: Steven.Kachelmeyer@med.ge.com |
| Device Trade Name: | Lunar DPX Series: (DPX-MD+, DPX-MD+ Compact , DPX-NT, DPX-NTCompact, DPX Pro, DPX Bravo, DPX Duo)Lunar Prodigy Series: (Prodigy, Prodigy Compact, Prodigy Pro, ProdigyPro Compact, Prodigy Primo, Prodigy Primo Compact, ProdigyAdvance, Prodigy Advance Compact, Prodigy Forma)Lunar iDXA Series: (iDXA, iDXA Advance, iDXA Pro, iDXA Forma, LunariDXA) |
| Common/UsualName: | Bone Densitometer |
| ClassificationNames: | Bone Densitometer (21CFR 892.1170) |
| Product Code: | KGI |
| Predicate Device(s): | Pediatric Reference Data for Prodigy and DPX Bone Densitometers(K001812) |
| Infant Whole Body Software Option for QDR Densitometers (K042480) | |
| Expert-XL Orthopedic Hip Acquisition and Analysis Software(K972517) | |
| Device Description: | enCORE software is used on GE Lunar DXA bone densitometers.Release 16 of the enCORE software (enCORE 16 or enCORE 16.xx)includes some feature enhancements. The software will now expandupon its previously cleared pediatric indication (K001812) byproviding a "Complete Pediatric" software that can measure the bonemineral content (BMC), bone mineral density (BMD) and bodycomposition (lean body mass and fat mass) in patients from birth to20 years of age. The software will also provide a comparison ofmeasured variables obtained by dual energy x-ray absorptiometry toa database of reference values for patients 5-19 years of age. Thesoftware will also expand its previously cleared orthopedic hipindication (K972517) to include estimates of the BMD of the kneebefore and after joint implant. |
| The GE Lunar DXA bone densitometers measure the bone mineraldensity (BMD), lean and fat tissue mass and calculate derivativevalues of bone mineral content (BMC), area, soft tissue mass, regionalsoft tissue mass, total soft tissue mass, fat free mass, regional/totalsoft tissue mass ratio, % fat, region % fat, total body % fat, Android %fat, Gynoid % fat, Android/Gynoid ratio (A/G ratio) and Body MassIndex (BMI). | |
| Intended Use: | The enCORE version 16 for GE Lunar DXA Bone Densitometers isintended for medical purposes to measure bone density, bonemineral content, and fat and lean tissue content by x-raytransmission measurements through the bone and adjacent tissues. |
| Technology: | The enCORE version 16 Software Release for the GE Lunar DXA BoneDensitometers employs the same fundamental scientific technologyas its predicate device, which is dual-energy x-ray absorptiometryusing a PC based image processing algorithm running on a MicrosoftWindows operating system. |
| The enCORE version 16 Software Release for the GE Lunar DXA BoneDensitometers has expanded the anatomical sites from the predicatedevices to now also include the knee for orthopedic examinations, preand post joint implant, with its optional orthopedic software. | |
| The enCORE version 16 Software Release for the GE Lunar DXA BoneDensitometers has expanded the patient population from thepredicate devices for the complete pediatric software option toaccommodate those populations from birth to 20 years of age. | |
| The differences discussed in this section do not raise new issues ofsafety and effectiveness. Verification and Validation testingdemonstrated that no adverse effects have been introduced by thesedifferences. | |
| Determination ofSubstantialEquivalence: | Summary of Non-Clinical Tests: |
| The enCORE version 16 Software Release for the GE Lunar DXA BoneDensitometers and its applications comply with voluntary standards.The following quality assurance measures were applied to thedevelopment of the system: | |
| ■ Risk Analysis | |
| ■ Requirements Reviews | |
| ■ Design Reviews | |
| ■ Testing on unit level (Module verification) | |
| ■ Integration testing (System verification) | |
| ■ Performance testing (Verification) | |
| ■ Safety testing (Verification) | |
| ■ Simulated use testing (Validation) | |
| Summary of Clinical Tests: | |
| The subject of this premarket submission, enCORE version 16Software Release for the GE Lunar DXA Bone Densitometers, did notrequire clinical studies to support substantial equivalence. Benchtesting was performed to verify the effectiveness of the expandedpopulation range of the "Complete Pediatric" software applicationfrom birth to 20 years as well as add the knee as an additionalanatomic site for the orthopedic software application. | |
| Conclusion: | The enCORE version 16 Software Release for the GE Lunar DXA BoneDensitometers expands upon its previously cleared pediatricindication (K001812) by broadening the patient population from birthto 20 years of age. The software will also expand its previouslycleared orthopedic hip indication (K972517) to include estimates ofthe BMD of the knee before and after joint implant. It does not resultin any new potential safety risks, has the same technologicalcharacteristics, and performs as well as the devices currently on themarket. |
| After analyzing performance testing on the bench it is the conclusionof GE Healthcare that the enCORE version 16 Software Release for theGE Lunar DXA Bone Densitometers e is substantially equivalent toother marketed devices with similar indications for use and meetingthe same standards. |
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GE Healthcare
510(k) Premarket Notification Submission
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GE Healthcare
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510(k) Premarket Notification Submission
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 15, 2014
GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC % Mr. Chris Paulik Regulatory Affairs Leader 3030 Ohmeda Drive MADISON WI 53718
Re: K133664
Trade/Device Name: enCORE version 16 software for GE Lunar DXA Bone Densitometers Regulation Number: 21 CFR 892.1170 Regulation Name: Bone densitometer Regulatory Class: II Product Code: KGI Dated: April 9, 2014 Received: April 10, 2014
Dear Mr. Paulik:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Chris Paulik
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/dcfault.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Smh.7)
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known) K133664
Device Name
enCORE version 16 for GE Lunar DXA Bone Densitometers
Indications for Use (Describe)
The optional "Complete Pediaric" software option mineral content (BMC), bone nineral density (BMD) and body composition (lean body mass and fat mass) in patients from birth to 20 years of age. The software provides a comparison of measured variables obtained by dual energy x-ray absorpionery to a database of reference values for patients 5-19 years of age. These data can be used for comparative purposes at the sole discretion of the software does not provide a reference population for comparative purposes for patients younger than 5 years of age.
Optional Orthopedic software estimates periprosthetic BMD of an orthopedic hip or knee implant (pre- and post-surgery).
Type of Use (Select one or both, as applicable)
🇿 Prescription Use {Part 21 CFR 801 Subpart D)
] Over-The-Counter Use (21 CFR 801 Subpart C)
Please do not write below this line - continue on a separate page if needed.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Sm)
FORM FDA 3881 (9/13)
Par Publishing Services . BOI : 441-12 Pr
§ 892.1170 Bone densitometer.
(a)
Identification. A bone densitometer is a device intended for medical purposes to measure bone density and mineral content by x-ray or gamma ray transmission measurements through the bone and adjacent tissues. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.